Olesoxime

DRUG5 trials

Conditions

Amyotrophic Lateral SclerosisHealthy VolunteerMuscular Atrophy, SpinalNeurological muscle degeneration Spinal muscular atrophySpinal Muscular Atrophy Type IISpinal Muscular Atrophy Type III Non Ambulant

Phase 1

A Study of the Excretion Balance of Radiocarbon and the Pharmacokinetics and Metabolic Profile of TRO19622 (Olesoxime)

CompletedNCT02835976

Hoffmann-La RocheHealthy Volunteer

Start: 2014-07-31End: 2014-09-30Updated: 2016-07-18

Phase 2

Safety and Efficacy of Olesoxime (TRO19622) in 3-25 Years SMA Patients.

CompletedNCT01302600

Hoffmann-La RocheSpinal Muscular Atrophy Type II, Spinal Muscular Atrophy Type III Non Ambulant

Start: 2010-11-30End: 2013-10-31Updated: 2016-11-22

A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients With Spinal Muscular Atrophy (SMA)

CompletedNCT02628743

Hoffmann-La RocheMuscular Atrophy, Spinal

Start: 2016-01-20End: 2018-12-18Updated: 2019-08-09

Phase 3

Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS

CompletedNCT00868166

Hoffmann-La RocheAmyotrophic Lateral Sclerosis

Start: 2009-04-30End: 2011-09-30Updated: 2020-02-25

Unknown Phase

An open-label, randomized, single center, adaptive, parallel group study to investigate the single dose oral pharmacokinetics (PK) properties of olesoxime formulated as an oral suspension and as an oral solution in the fed state

Active, not recruitingNL-OMON45676

Hoffmann-La RocheNeurological muscle degeneration Spinal muscular atrophy

Start: 2016-10-18Target: 90Updated: 2024-02-28

Journal of Neurology2024-05-1123 citations

Risdiplam in Patients Previously Treated with Other Therapies for Spinal Muscular Atrophy: An Interim Analysis from the JEWELFISH Study.

2023-02-1335 citations

Two-year efficacy and safety of risdiplam in patients with type 2 or non-ambulant type 3 spinal muscular atrophy (SMA).

2023-02-0362 citations

187 SUNFISH Part 2: 24-month efficacy of risdiplam compared with external control comparators

Journal of Neurology Neurosurgery & Psychiatry2022-08-121 citations

Neurofilament light and heterogeneity of disease progression in amyotrophic lateral sclerosis: development and validation of a prediction model to improve interventional trials.

2021-08-2633 citations

Prospective and longitudinal natural history study of patients with Type 2 and 3 spinal muscular atrophy: Baseline data NatHis-SMA study

PLoS ONE2018-07-26146 citations

A Long-Term, Open-Label Follow-Up Study of Olesoxime in Patients with Type 2 or Non-Ambulatory Type 3 Spinal Muscular Atrophy who Participated in a Placebo-Controlled Phase 2 Trial (S46.002)

Neurology2018-04-102 citations

Safety and efficacy of olesoxime in patients with type 2 or non-ambulatory type 3 spinal muscular atrophy: a randomised, double-blind, placebo-controlled phase 2 trial.

2017-04-2885 citations